Industrial chemicalsover 5 decadesBy Finn Bro-Rasmussen, former president of EU/CSTE, Prof. emer., DTU Denmark

Chemical risks illustrated- over 3 decades

EINECS (1981) a register of100.106 EXISTING chemicals

The EU chemical universe

100.000 EXISTING CHEMICALS : 2.700 > 1000 tons / yr (HPVC)10.000 > 10 tons / yr 30-40.000 > 1 tons / yr

For all other chemicals NONEThe empty data bases For further 10-20.000 chemicals: Scattered/single tox.-data may be available 50-150 EU priority chemicals Adequate tox. Data - inadequate exposure dataGood data on 14%Incomplete data on65%No data on 21%

Principles of EU chemicalsregulation

The rationale of toxicological protection levelsAdverse effects(diff. species- various effects)100%

50%

0%Exposure conc. (mg/kg)Precaution requiredSafety requirements

Quality standards & limit values- exemplifiedAdverse effects?(PBDE?)

Hazard - risk assessment

Risk-ratio

Chemicals assessment

Risk-ratioIdentifying uncertainties

The prevalent underclassification19-20% of HPV chemicals are classified, - only 3-4% of all LPV & MPV chemicals ?

15% of ca. 1000 EU hazardous chemicals are underclassified if related to data from RTECS database (cf. Swedish report, 2003)

QSAR-evaluations suggest 44% of 42.000 EINECS chemcials are classifiable (cf. Danish EPA-report, 2002)

Group/category evaluations suggestedEXAMPLESAPPLICATIONS

Alkylated phenolsOil / lubricants, additivesBenzimidazolesHerbicidesBrominated flame-retardantsPlast, textiles, electronicsCadmium saltsElectronics, plast, batteriesChlorinated pesticides & other POP chemicals In agri- & horticulture. Indust. & consumer prod.Linear Alkylsulfonates (LAS)Wash & clean productsPhthalatesPVC-plast, paints, cosmeticsSiloxanes, cyclicIndustrial oils, cosmetics & personal care productsTriazine herbicidesHerbicides

QSAR models applied on 47.000 EINECSsubstances have indicated that:

Acute toxicitySkin sensitizationMutagenicityCancerogenicity Ecotoxicity

20.624 or 44 %

are found positive i.e.to be classified

QSAR (= Quantative Structure Activity Relationship)*) cf. Danish EPA: Report on QSAR to OECD, 2003

Industrial chemicals over two decades Nordic countries EU1981 EINECS register & Nordic productregisters1995 Expert report to Danish Parliament on non-assessed chemicals 1996 The Esbjerg declaration generation target1997 Swedish Chemical Strategy1998 Danish List of unwanted chemicals2000 Swedish Chemical Strategy2000 Copenhagen declaration 5 demands2001 EU - White paper & Council resolution2002 EU - Technical consultations2003 REACH

5 key demands(The Copenhagen declaration 2000)1THE RIGHT TO KNOW

2All marketed chemicals to be tested and evaluated -PRECAUTIONARY PRINCIPLE

3Phasing out of all persistant and bioaccumulating substances- BANNING OF THE POPs

4Hazardous chemicals to be substituted for less hazardous SUBSTITUTION REQUIREMENT

5All emissions of hazardous chemicals to be stopped by 2020 GENERATION TARGET

Basic political requirementscf. Council resolutions, March/June 2001 Precautionary and substitution principlesAll chemicals (no data- no marketing)Registration and testing of chemical substances requiredSafety evaluations based on risk assess- ment not by volumeResponsibility for data and risk assessment on producers, importers and downstream users

REACH proposal:A way forward!

The background